Tenaya Therapeutics Announces Rapid Resolution and Lifting of Clinical Hold for MyPEAK-1™ Phase 1b/2a Clinical Trial of TN-201 Gene Therapy [Yahoo! Finance]
Tenaya Therapeutics, Inc. (TNYA)
Company Research
Source: Yahoo! Finance
SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced it has received official notification from the U.S. Food and Drug Administration (FDA) that the clinical hold on the MyPEAK-1™ Phase 1b/2a clinical trial of TN-201 has been removed. All concerns raised by the FDA related to the clinical hold have been addressed. TN-201 is being developed for the potential treatment of Myosin Binding Protein C3 (MYBPC3) -associated hypertrophic cardiomyopathy (HCM), a condition caused by insufficient levels of myosin-binding protein C (MyBP-C). Tenaya is currently implementing amendments to the study protocol in collaboration with MyPEAK-1 clinical sites after which the company plans to resume dosing. The protocol changes standardize practices adopted in the tria
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TNYA
News
- Tenaya Therapeutics (NASDAQ:TNYA) had its price target lowered by analysts at HC Wainwright from $5.00 to $3.00. They now have a "buy" rating on the stock.MarketBeat
- Tenaya Therapeutics (NASDAQ:TNYA) had its price target lowered by analysts at Chardan Capital from $9.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
- Tenaya Therapeutics Announces Pricing of Public OfferingGlobeNewswire
- Tenaya Therapeutics Announces Proposed Public Offering [Yahoo! Finance]Yahoo! Finance
- Tenaya Therapeutics Reports Positive Interim Data from Cohort 1 of RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Gene Therapy for Adults with PKP2-associated ARVC [Yahoo! Finance]Yahoo! Finance
TNYA
Earnings
- 11/10/25 - Beat
TNYA
Sec Filings
- 12/12/25 - Form 8-K
- 12/12/25 - Form 424B5
- 12/11/25 - Form 424B5
- TNYA's page on the SEC website